Suprovia

Package Leaflet: Information for the Patient

Suprovia, 50 mg, Film-Coated Tablets

Suprovia, 100 mg, Film-Coated Tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Suprovia and what is it used for
• 2. Important information before taking Suprovia
• 3. How to take Suprovia
• 4. Possible side effects
• 5. How to store Suprovia
• 6. Contents of the pack and other information

1. What is Suprovia and what is it used for

Suprovia contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar made by the body.
Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high due to type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking for your diabetes, together with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not produce enough insulin, and the insulin it does produce does not work properly. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and foot amputation.

2. Important information before taking Suprovia

When not to take Suprovia

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In patients taking Suprovia, cases of pancreatitis have been reported (see section 4).
If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Suprovia.
Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these cases, the risk of pancreatitis may be increased (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney problems, now or in the past;
• an allergic reaction to Suprovia (see section 4).

Because this medicine does not work when your blood sugar is low, it is unlikely to cause low blood sugar. However, when taken with a sulfonylurea or insulin, it may cause low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Do not take this medicine if you are under 18 years old. This medicine is not effective in children and adolescents from 10 to 17 years old. It is not known if this medicine is safe and effective when used in children under 10 years old.

Suprovia with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart rhythm and other heart conditions). When taking Suprovia with digoxin, your doctor may check your digoxin levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy.
It is not known if this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you are planning to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar (hypoglycemia), which may affect the ability to drive and use machines or work without safe foot support.

Suprovia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially 'sodium-free'.

3. How to take Suprovia

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet;
• once a day;
• taken by mouth.

If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may prescribe this medicine alone or with other medicines that lower blood sugar levels.
Diet and exercise help your body use blood sugar better. While taking Suprovia, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Suprovia than you should

If you take more than the recommended dose, contact your doctor immediately.

If you forget to take Suprovia

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose of this medicine.

If you stop taking Suprovia

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Suprovia and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your diabetes.

In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, vomiting, diarrhea
Uncommon (may affect up to 1 in 100 people): stomach pain, constipation, drowsiness
In some patients, when sitagliptin was taken in combination with metformin, the following side effects were reported (common): gastrointestinal symptoms.

In some patients, when sitagliptin was taken in combination with a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
In some patients, when sitagliptin was taken in combination with pioglitazone, the following side effects were reported:
Common: diarrhea, swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In clinical studies, when sitagliptin was taken alone or with other anti-diabetic medicines, the following side effects were reported:
Common: low blood sugar, headache, upper respiratory tract infections, sore throat and sinusitis, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suprovia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information What Suprovia contains

Suprovia, 50 mg

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium carmellose (E 468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E 470b). Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), yellow iron oxide (E 172), and red iron oxide (E 172).

Suprovia, 100 mg

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium carmellose (E 468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E 470b). Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), yellow iron oxide (E 172), and red iron oxide (E 172).

What Suprovia looks like and contents of the pack

Suprovia 50 mg: round, light beige film-coated tablet, 8 mm in diameter, with 'S' engraved on one side.
Suprovia 100 mg: round, beige film-coated tablet, approximately 10 mm in diameter.
The pack contains 30 film-coated tablets in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sp. z o.o.
Jerozolimskie Avenue 142B
02-305 Warsaw
phone: +48 22 53 59 700

Manufacturer

SAG MANUFACTURING, S.L.U.
N-I Road, Km 36, San Agustín de Guadalix
28750 Madrid
Spain
GALENICUM HEALTH, S.L.
Cornella Avenue 144, 7º 1ª
08950 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Suprovia: Spain, Malta, Poland, Romania

Date of last revision of the package leaflet: 17.01.2023